Back to resultsEffects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee
Primary Purpose
Chronic Pain, Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring transcranial direct current stimulation, transcranial ultrasound
Eligibility Criteria
STUDY ELIGIBILITY CRITERIA
Inclusion Criteria:
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
- Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
- Must have the ability to feel pain as self reported
Exclusion Criteria:
- Subject is pregnant.
Contraindications to tDCS:
- metal in the head
- implanted brain medical devices
Contraindications to TUS:
- metal in the head
- implanted brain medical devices
- History of alcohol or drug abuse within the past 6 months as self reported
- Use of carbamazepine within the past 6 months as self reported.
- Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
- History of neurological disorders as self reported.
- History of unexplained fainting spells as self reported,
- History of head injury resulting in more than a momentary loss of consciousness as self reported
- History of neurosurgery as self reported
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS + transcranial ultrasound
Sham tDCS + transcranial ultrasound
Arm Description
Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.
Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.
Outcomes
Primary Outcome Measures
Changes in pain scale
Determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with chronic osteoarthritis pain, as measured by changes in the Visual Analogue Scale (VAS) for pain. VAS will be measured immediately before the tDCS stimulation sessions, and immediately after the tDCS stimulation sessions for the subject's duration in the trial. VAS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Secondary Outcome Measures
Changes in cutaneous allodynia/hyperalgesia
To investigate whether stimulation with active anodal tDCS with ultrasound (applied in a diagnostic mode) alters the phenomenon of central sensitization, as indexed by cutaneous allodynia and hyperalgesia, measured by the pain perception threshold as compared with sham tDCS. Pain measurements will be measured immediately before the tDCS stimulation sessions, and immediately after for the subject's duration in the trial. Pain measurements will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Assessment of hemodynamic changes with transcranial ultrasound
To investigate hemodynamic changes in the brain that may occur due to tDCS as measured by transcranial ultrasound. Blood flow measured by TUS will be measured immediately before during and after the tDCS stimulation sessions, for the subject's duration in the trial. Blood flow measured by TUS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Full Information
NCT ID
NCT01404052
First Posted
June 29, 2011
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01404052
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee
Official Title
Effects of Transcranial Direct Current Stimulation and Transcranial Ultrasound on the Perception of Pain Due to Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 30, 2014 (Actual)
Study Completion Date
July 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Highland Instruments, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Osteoarthritis
Keywords
transcranial direct current stimulation, transcranial ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS + transcranial ultrasound
Arm Type
Experimental
Arm Description
Subjects will undergo 20 minutes active tDCS in conjunction with transcranial ultrasound measurements.
Arm Title
Sham tDCS + transcranial ultrasound
Arm Type
Sham Comparator
Arm Description
Subjects will receive sham tDCS in conjunction with transcranial ultrasound measurements.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
low intensity 1x1 direct current stimulator
Intervention Description
Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2 and an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.
Primary Outcome Measure Information:
Title
Changes in pain scale
Description
Determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with chronic osteoarthritis pain, as measured by changes in the Visual Analogue Scale (VAS) for pain. VAS will be measured immediately before the tDCS stimulation sessions, and immediately after the tDCS stimulation sessions for the subject's duration in the trial. VAS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Time Frame
Measured for approximately 2 months
Secondary Outcome Measure Information:
Title
Changes in cutaneous allodynia/hyperalgesia
Description
To investigate whether stimulation with active anodal tDCS with ultrasound (applied in a diagnostic mode) alters the phenomenon of central sensitization, as indexed by cutaneous allodynia and hyperalgesia, measured by the pain perception threshold as compared with sham tDCS. Pain measurements will be measured immediately before the tDCS stimulation sessions, and immediately after for the subject's duration in the trial. Pain measurements will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Time Frame
Measured for approximately 2 months
Title
Assessment of hemodynamic changes with transcranial ultrasound
Description
To investigate hemodynamic changes in the brain that may occur due to tDCS as measured by transcranial ultrasound. Blood flow measured by TUS will be measured immediately before during and after the tDCS stimulation sessions, for the subject's duration in the trial. Blood flow measured by TUS will also be measured at baseline, and at three follow-up sessions after tDCS stimulation (up to 2 months after tDCS stimulation)
Time Frame
Measured for approximately 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
STUDY ELIGIBILITY CRITERIA
Inclusion Criteria:
Providing informed consent to participate in the study
18 to 64 years old
Having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
Must have the ability to feel pain as self reported
Exclusion Criteria:
Subject is pregnant.
Contraindications to tDCS:
metal in the head
implanted brain medical devices
Contraindications to TUS:
metal in the head
implanted brain medical devices
History of alcohol or drug abuse within the past 6 months as self reported
Use of carbamazepine within the past 6 months as self reported.
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
History of neurological disorders as self reported.
History of unexplained fainting spells as self reported,
History of head injury resulting in more than a momentary loss of consciousness as self reported
History of neurosurgery as self reported
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital (SRH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee
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